Recall of Similasan iVIZIA Sterile Lubricant Eye Drops
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Thea Pharma, Inc. is voluntarily recalling specific lots of Similasan iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility identified by FDA inspections.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
What Happened
Thea Pharma, Inc. is recalling certain lots of Similasan iVIZIA Sterile Lubricant Eye Drops because of a lack of assurance of sterility, stemming from CGMP deviations found by the FDA during an inspection of the manufacturer.
Which Products Are Affected
The affected product is Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, with NDC 59262-700-11. The specific lots are Lot# 5S30B and 5S30C with an expiration date of April 30, 2026, and Lot# 5S31B and 6S57B with an expiration date of May 31, 2026. The recall affects products distributed nationwide within the United States, with no specific quantity provided.
What You Should Do
Consumers who have the affected products should follow the initial firm notification, which was issued via letter, and contact Thea Pharma, Inc. for instructions on returns or refunds. No specific contact information is provided in the recall details.
Why This Matters
This recall highlights potential risks associated with non-sterile eye drops, which could affect product safety for consumers relying on these items for eye care. It underscores the importance of maintaining proper manufacturing standards to ensure public health.
Source
This information is from the FDA recall notice, recall number D-0501-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,380 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.